Safety needle assembly

ABSTRACT

The present invention is a safety shield assembly having a shield and a collar for connecting the shield to a fluid handling device whereby the shield may be pivoted with respect to the collar. Preferably, the safety shield assembly may be used with a needle assembly, an intravenous infusion set a syringe, a catheter or other fluid handling devices or assemblies that contain piercing elements. The shield includes a cannula channel with a finger lock for preventing re-exposure of the used needle.

RELATED APPLICATION

This application is a continuation-in-part of U.S. patent applicationSer. No. 09/378,976, filed Aug. 23, 1999 now U.S. Pat. No. 6,440,104.

FIELD OF THE INVENTION

The present invention relates to a shield for a needle and moreparticularly to a safety shield assembly that may be used in conjunctionwith a syringe assembly, a hypodermic needle, a needle assembly, aneedle assembly with a needle holder, a blood collection needle, a bloodcollection set, an intravenous infusion set or other fluid handingdevices or assemblies that contain piercing elements.

BACKGROUND OF THE INVENTION

Disposable medical devices having piercing elements for administering amedication or withdrawing a fluid, such as hypodermic needles, bloodcollecting needles, fluid handling needles and assemblies thereof,require safe and convenient handling. The piercing elements include, forexample, pointed needle cannula or blunt ended cannula.

Safe and convenient handling of disposable medical devices is recognizedby those in the medical arts so as to minimize exposure to blood bornepathogens. Safe and convenient handling of disposable medical devicesresults in the disposal of the medical devices intact.

As a result of this recognition, numerous devices have been developedfor shielding needles after use. Many of these devices are somewhatcomplex and costly. In addition, many of these devices are cumbersome touse in performing procedures. Furthermore, some of the devices are sospecific that they preclude use of the device in certain procedures orwith certain devices and/or assemblies. For example, some devices employvery short thin needle cannulas. A shield designed to lock near thedistal end of one needle cannula might not engage a much shorter needlecannula. Additionally, a shield designed to lock with a wider gaugeneedle cannula might be more likely to generate a spray upon engaging amuch narrower needle cannula. Furthermore, it may be desirable to reducethe force required to effect shielding without reducing the audible andtactile indications of complete shielding.

Therefore, there exists a need for a safety shield assembly: (i) that ismanufactured easily; (ii) that is applicable to many devices; (iii) thatis simple to use with one hand; (iv) that can be disposed of safely; (v)that does not interfere with normal practices of needle use; (vi) thathas tactile features whereby the user may be deterred from contactingthe needle, the user may easily orient the needle with the patient andeasily actuate and engage the shield assembly; (vii) that has visualfeatures whereby the user may be deterred from contacting the needle,the user may easily orient the needle with the patient and easilyactuate and engage the shield assembly; (viii) that is not bulky; (ix)that includes means for minimizing exposure to the user of residualfluid leaking from the needle; and (x) provides minimal exposure to theuser because the needle shield is immediately initiated by the userafter the needle is withdrawn from the patient's vein.

SUMMARY OF THE INVENTION

The present invention is a safety shield assembly that comprises: ashield; means for connecting the shield to a fluid handling device thatcontains a piercing element, such as needle; means for pivoting theshield away from the needle; and means for securely covering and/orcontaining the needle within the shield.

Preferably, the shield comprises a rearward end, a forward end, a slotor longitudinal opening for housing the used needle in the forward end,means for securing the needle in the slot, means for guiding the needleinto the slot, means for connecting the shield and the fluid handlingdevice, means for guiding the user's fingers to move the shield intovarious positions, and means for retaining the shield securely over theused needle.

Desirably, the means for connecting the shield to the fluid handlingdevice is a collar. Preferably, the shield is connected movably to acollar which is connected to a fluid handling device.

Preferably, the shield is connected to the collar by a hanger bar thatengages with a hook arm on the collar so that the shield may be pivotedwith respect to the collar into several positions. It is within thepurview of the present invention to include any structure for connectingthe shield to the collar so that the shield may be pivoted with respectto the collar. These structures include known mechanical hinges andvarious linkages, living hinges, or combinations of hinges and linkages.

Most preferably, the shield is connected to the collar by aninterference fit between the hanger bar and the hook bar. Therefore, theshield always is oriented in a stable position and will not move forwardor backwards unless movement of the shield relative to the hanger barand the hook bar is initiated by the user.

Alternatively, the collar and at least a portion of the shield may be aunitary one-piece structure. The one-piece structure may be obtained bymany methods, including molding the shield and the collar as a one-pieceunit, thereby eliminating the separate shield and collar during themanufacturing or assembly process.

The assembly of the present invention may further comprise tactile andvisual means for deterring the user from contacting the needle,providing easy orientation of the needle with the patient and providingthe user with a guide for actuation and engagement with the shield.

The assembly of the present invention may further comprise means forminimizing exposure by the user to residual fluid leaking from a usedneedle. For example, a polymer material, such as a gel, may be locatedin the shield.

Most desirably, the assembly of the present invention is such that thecooperating parts of the assembly provide the means for the shield tomove into a forward position over the needle. Thus, by simple movementof the shield into a forward position over the used needle, the assemblyis ready for subsequent disposal. Therefore, the safety shield assemblyof the present invention provides minimal exposure of the user to aneedle because the shielding is initiated by the user immediately afterthe needle is withdrawn from the patient's vein.

Desirably, the assembly of the present invention may be used with asyringe assembly, a hypodermic needle, a needle assembly, a needleassembly with a needle holder, a blood collection set, an intravenousinfusion set or other fluid handling devices. Preferably, the assemblyof the present invention is used with a needle assembly comprising aneedle and a hub. Preferably the needle is a conventional double endedneedle.

Most preferably, the present invention is used with a needle assemblycomprising a hub and a needle connected to the hub whereby the needlecomprises a non-patient end and an intravenous end. The collar of thepresent invention may comprise a hook arm and the shield may beconnected movably to the hook arm. Thus the shield may be pivoted withrespect to the collar and moved easily into several positions.

Preferably, the collar is fitted non-rotatably with the hub of theneedle assembly. Additionally, the collar includes cooperating meansthat mate with reciprocal means on the shield to provide a clear audibleand tactile indication of shielding. The cooperating means on the collarmay include generally chevron-shaped projection formed on a side of thecollar substantially diametrically opposite the hook arm or other suchstructure that provides the hinge connection to the shield. Thechevron-shaped structure includes a forward or distal point. Slantingsurfaces diverge and extend proximally from the distal point. Theslanting surfaces cooperate with the reciprocal means on the shield togenerate a deflection of the sidewalls of the shield away from oneanother. The chevron-shaped structure further includes proximal endsthat are convexly arcuate. The convexly arcuate ends of thechevron-shaped structure on the collar cooperate with the reciprocalmeans on the shield and with the resiliently deflectable sidewalls ofthe shield to generate the tactile and audible indication of shielding.

The shield preferably includes a proximal or rearward portion that ishingedly connected to the collar and a distal or forward portion thatcomprises a support extending unitarily from the rearward portion of theshield. The shield may further comprise a cannula channel securelymounted to at least the support of the forward portion. The channel maycomprise a top wall securely connected to the support of the shield anda pair of opposed spaced apart sidewalls extending downwardly from thetop wall. The spacing between the sidewalls is selected to accommodatethe needle cannula in the channel. At least one of the sidewalls of thecannula channel is formed with at least one cannula finger lock thatprojects angularly toward the top wall of the cannula channel. Thecannula finger lock is dimensioned, disposed and aligned to contact theneedle cannula when the shield approaches the second position. Contactbetween the needle cannula and the cannula finger lock will cause thecannula finger lock to resiliently deflect toward the sidewall fromwhich the cannula finger lock extends. Sufficient rotation of the shieldwill cause the needle cannula to pass the cannula finger lock. As aresult, the cannula finger lock will resiliently return to or toward itsundeflected condition for securely trapping the needle cannula in theshield.

The top wall of the cannula channel may comprise means for engagingreciprocal means on the support of the forward portion of the shield.The mounting means on the cannula channel may be disposed in anon-central position relative to the longitudinal direction of thechannel. Thus, the cannula channel can be mounted to the shield supportin either of two alternate orientations that are rotated 180° from oneanother. In a first rotational orientation, the cannula channel projectsdistally or forwardly beyond the support of the shield. In a secondrotational orientation, the cannula channel projects rearwadly orproximally from the support of the shield to overlie the rearwardportion of the shield. Thus, the first rotational orientation of thecannula channel ensures that the pointed distal end of a long needlecannula is surrounded by the cannula channel and engaged by the cannulafinger locks. The second rotational orientation of the cannula channelensures that a shorter needle cannula is surrounded by the cannulachannel and engaged by the cannula finger locks.

The cannula channel may have a proximal or rear end configured forengaging the collar or hub when the shield is in its second position.Engagement of the channel with the collar or hub may contribute tolocked retention of the shield in the second position. Additionally,engagement of the proximal end of the cannula channel with the collar orhub may further support the channel and prevent excessive deformation ofthe channel.

Preferably, the collar is fitted with the hub of the needle assembly sothat the collar cannot rotate around the hub. Alternatively, the collarand hub may be a unitary one-piece structure. The one piece structuremay be accomplished by many methods including molding the collar and thehub as a one-piece unit thereby eliminating the need to separatelyassemble the collar to the hub during the manufacturing process.

Most preferably, the collar is fitted with the hub of the needleassembly so that the bevel surface or bevel up surface of theintravenous or distal end of the needle faces the same side of thecollar when the shield is in the first position. Alignment of thecollar, hub, shield and needle with the bevel surface up makes it easierto insert the needle into the patient without manipulating the assembly.The orientation of the intravenous end of the needle with the bevel upassures the user that the needle is properly oriented for use and doesnot require any manipulation before use. Most notably, the orientationof the shield provides a visual indication to the user of theorientation of the bevel surface of the needle.

Preferably, the shield is capable of pivoting from a first positionwhere the intravenous end of the needle is exposed and bevel up, to anintermediate position where the needle is partially covered, to a secondposition where the needle is covered completely.

Alternatively, it is within the purview of the present invention thatthe collar, hub and at least a portion of the shield may be a unitaryone-piece structure. The one-piece structure may be accomplished by manymethods including molding the shield, collar and hub as a one-piece unitthereby eliminating the need to separately assemble the shield, collarand hub during the manufacturing process.

It is an advantage of the present invention that the shield covering theused intravenous end of the needle provides easy containment of the usedneedle. A further advantage of the shield is that it will only move uponinitiation by the user.

The assembly of the present invention when used with a fluid handlingdevice is also easily disposable when removed from a conventional needleholder, or other such device.

A notable attribute of the present invention is that it is easilyadaptable with many devices. For example, the invention is usable withsyringe assemblies, hypodermic needles, needle holders, blood collectionneedles, blood collection sets, intravenous infusion sets such ascatheters or other fluid handling devices or assemblies that containpiercing elements.

Another notable attribute of the present invention is that the tactileand visual features deter the user from touching the needle, allow theuser to easily orient the needle with the patient and guide the user toactuate and engage the shield of the assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the safety shield assembly of thepresent invention as connected to a needle assembly and relatedpackaging features.

FIG. 2 is a perspective view of the unassembled pieces of FIG. 1.

FIG. 3A is a bottom view of the shield as shown in FIG. 2.

FIG. 3B is an enlarged bottom view of an ear of the shield.

FIG. 4 is a cross sectional view of the collar as shown in of FIG. 2taken along lines 4—4 thereof.

FIG. 5 is a cross sectional view of the needle hub as shown in FIG. 2taken along lines 5—5 thereof.

FIG. 6A is a cross sectional view of the shield of FIG. 2 taken alonglines 6A—6A thereof.

FIG. 6B is a cross-sectional view similar to FIG. 6A, but showing thecannula channel in an end-to-end reversed orientation.

FIGS. 7-12 illustrate the use of the safety shield assembly with theneedle assembly of FIG. 1 with a conventional needle holder.

FIG. 13 is a cross sectional view of the assemblies in use with aconventional needle holder as shown in FIG. 12 taken along lines 13—13thereof.

FIG. 14 is a cross-sectional view of the assemblies of FIG. 13 takenalong lines 14—14 thereof.

FIG. 15A is a bottom view of the assemblies as shown in FIG. 11.

FIG. 15B is an enlarged bottom view showing the engagement of the earand the chevron-shaped projection.

FIG. 16 illustrates an additional embodiment of the present invention,whereby a gel material is located in the shield as shown in a bottomview of the assemblies of FIG. 11.

FIG. 17 is a perspective view of an additional embodiment of the presentinvention in use with a blood collection set.

FIG. 18 is a perspective view of an additional embodiment of the presentinvention in use with a syringe.

FIG. 19 is a perspective view of an additional embodiment of the presentinvention in use with a catheter.

FIG. 20 is an exploded side elevational view of an additional embodimentof the present invention.

FIG. 21 is a bottom view of the clip of FIG. 20.

FIG. 22 is a bottom view of the assembly similar to FIG. 15A, butshowing an additional embodiment of the present invention without achevron-shaped structure on the collar and without locking ears on theshield.

DETAILED DESCRIPTION OF THE INVENTION

While this invention is satisfied by embodiments in many differentforms, there is shown in the drawings and will herein be described indetail, the preferred embodiments of the invention, with theunderstanding that the present disclosure is to be considered asexemplary of the principles of the invention and is not intended tolimit the invention to the embodiments illustrated. Various othermodifications will be apparent to and readily made by those skilled inthe art without departing from the scope and spirit of the invention.The scope of the invention will be measured by the appended claims andtheir equivalents.

Referring to the drawings in which like reference characters refer tolike parts throughout the several views thereof, FIGS. 1 and 2illustrate a needle assembly with the safety shield assembly of thepresent invention and the related packaging features. The needleassembly includes a needle 40, a hub 60, packaging features to cover theneedle and a label. The safety shield assembly includes a collar 90 anda shield 140.

As shown in FIGS. 2 and 5, needle 40 includes a non-patient end 42, anintravenous end 44 and a passageway 62 extending between the non-patientend and the intravenous end. An elastomeric sleeve 48 covers thenon-patient end. A first rigid sleeve 50 covers the intravenous end anda second rigid sleeve 52 covers the non-patient end and the elastomericsleeve. As shown in FIG. 1, a label 196 may also be applied to thefinally assembled parts.

As shown in FIGS. 2 and 5, hub 60 includes a threaded end 64, a ribbedend 66 and passageway 62 extending between the threaded end and theribbed end. Threaded end 64 and ribbed end 66 are separated by flange68. Non-patient end 42 of needle 40 extends from threaded end 64 andintravenous end 44 of needle 40 extends from ribbed end 66. Preferably,threaded end 64 comprises male threads 80 for mounting the hub on aconventional needle holder and ribbed end 66 comprises male ribs 82 forconnecting the hub and collar 90.

As shown in FIGS. 2 and 4, collar 90 includes a forward skirt 92 and arearward skirt 94. Forward skirt 92 is cylindrical and comprises aninner circumferential surface 96 and an outer circumferential surface98. Forward skirt 92 mates with rearward skirt 94 at a shoulder 100.Rearward skirt 94 is cylindrical and comprises an inner circumferentialsurface 102 and an outer circumferential surface 104 and extends fromshoulder 100 opposite of forward skirt 92. The inner diameter of forwardskirt 92 is larger than the inner diameter of rearward skirt 94.Alternatively, the inner diameters for collar 90 can be equal. A hook114 extends from outer circumferential surface 98 of forward skirt 92.Additionally a chevron-shaped protrusion 118 projects outwardly fromouter circumferential surface 98 of forward skirt 92 at a side oppositehook 114. The chevron-shape protrusion 118 is substantially symmetricaland has a peak 120 pointed toward forward skirt 92 and ramp surfaces 122that diverge symmetrically from peak 120 toward rearward skirt 94. Rampsurfaces 122 terminate at rounded ends 124 at the outer side andproximal extremes of chevron-shaped protrusion 118. Rounded ends 124extend continuously into the proximal side of chevron-shaped protrusion118 facing toward rearward skirt 94.

As shown in FIGS. 2 and 6, shield 140 comprises a rearward end 144 and aforward end 146. Forward end 146 of shield 140 defines an elongatesupport wall 150 with a distal end 152 and top and bottom surfaces 154and 156 extending proximally from distal end 152. In the illustratedembodiment, top and bottom surfaces 154 and 156 are slightly arcuatefrom side-to-side. However, in other embodiments, top surface 154 and/orbottom surface 156 may be substantially planar. Support wall 152 ischaracterized by axially spaced apertures 158 extending entirelytherethrough from top surface 154 to bottom surface 156.

Rearward end 144 of shield 140 defines a collar engaging area 166.Collar engaging area 166 includes a rearward end 168, a forward end 170,a top finger guide area 172, sidewalls 174 that extend downwardly fromtop finger guide area 172, an underside area 176 dimensioned forsurrounding collar 90, and extending arms 180 to support hanger bar 182.Sidewalls 174 are spaced apart by a major width adjacent rearward end168. The major width is selected to enable sidewalls 174 to slide acrossdiametrically opposite side surfaces of forward skirt 92 of collar 90.Sidewalls 174 converge, however, toward forward end 170 to define aminor distance therebetween. Sidewalls 174 include bottom edges 177 thatface away from top finger guide area 172. As shown most clearly in FIG.6, bottom edges 177 curve toward top finger guide area 172 at locationsbetween rearward end 168 and forward end 170 of collar engaging area166.

Shield 140 further includes a cannula channel 220. Cannula channel 220includes opposed longitudinal ends 222 and 224, an elongate convex outersurface 226 extending between ends 222 and 224 and an inner concavesurface 228 extending between ends 222 and 224. An entry to concaveinner surface 228 is defined by opposed parallel edges 230 that extendsubstantially between ends 222 and 224 of channel 220. Mountingprojections 232 project from convex outer surface 226 at a locationsubstantially equally spaced from edges 230. Thus, mounting projections232 are substantially opposite from the entry into concave inner surface228 of channel 220. Mounting projections 232 are spaced from one anotherby a distance substantially equal to the spacing between mountingapertures 158 in support wall 150. Additionally, mounting projections232 are dimensioned to be snapped or force fit into apertures 158.Mounting projections 232 are not symmetrically disposed along the lengthof cannula channel 220. Rather, mounting projections 232 are closer toend 222 than to end 224. Channel 220 is defined further by cannulafinger locks 234 that project obliquely inwardly from one of side edges230. Cannula finger locks 234 are resiliently deflectable in response toforces exerted by needle 40 as explained further below.

The extreme rear ends of sidewalls 174 on collar engaging area 166include rounded ears 194 that project toward one another from opposedinner surfaces 175 of sidewalls 174. Rounded ears 194 are disposed toengage chevron-shaped projection 118 on collar 90. More particularly,each rounded ear 194 includes a distal surface 195, a proximal surface197 and a curved surface 198 extending between distal and proximalsurfaces 195 and 197. Distal surface 194 is aligned to sidewall 174 at arake angle of approximately 60° and proximal surface 197 is aligned tosidewall 174 at an angle of approximately 45°. Curved surface 198extends smoothly and convexly between distal and proximal surfaces 195and 197. Proximal surfaces 197 of rounded ears 194 will engage rampsurfaces 122 of chevron-shaped projection 118 to deflect sidewalls 174slightly away from one another as shield 140 approaches the secondposition. The apex of curved surface 198 on each rounded ear 194 passesthe respective rounded end surface 124 on chevron-shaped projection 118on collar 90. As a result, sidewalls 174 begin to return resilientlytoward an undeflected condition. The resilient return of sidewalls 174and raked distal surface 195 of ears 194 causes sidewalls 174 to snapagainst chevron-shaped projection 118. This snapping action provides aclear audible and tactile indication of complete shielding and occurssubstantially when the used needle is trapped by cannula finger locks234. The angles of distal and proximal surfaces 195 and 197 of roundedears 194 affects the performance of shield 140. In particular, a smalleracute angle alignment of proximal face 197 reduces the force required tomove shield 140 passed rounded ears 194. A larger acute angle proximalsurface 197 of rounded ears 194 requires a greater force to move shield140 toward the second position. Similarly, the angle between distalsurface 195 and sidewall 174 affects the acceleration characteristics asshield 140 is propelled toward the second position in response to theresilient return of sidewalls 174. This change in accelerationcharacteristics affects the audible indication of shielding. Differentaudible and acceleration characteristics can be achieved by employingmore sharply pointed corners on the end surface of chevron-shapedprojection 118 for engagement by rounded ears 194 of shield 140.

Top finger guide area 172 comprises a first ramp 184 that extendsslightly on an upwardly slope from the rearward end of the collarengaging area to a shoulder 186. From shoulder 186 extends a second ramp188 which slopes downwardly towards support wall 150. Most preferably,first ramp 184 comprises touch bumps 190. The touch bumps provide atactile and visual guide to alert the user that the user's finger hascontacted the shield and that the shield is in a defined or controlledposition. The touch bumps may be any configuration so long as theyextend and are distinct from the top finger guide area. The touch bumpsmay also be of a distinguishing color as compared to the top fingerguide area or the shield.

Second ramp 188 has interior surface 192 for urging the needle towardthe center as the shield is being rotated into the closed position. Theexterior surfaces are slightly inclined and extending radially from thesecond ramp. The interior surfaces are especially helpful if thelongitudinal axis of the needle is misaligned with respect to thelongitudinal axis of the hub.

Extending arms 180 are located at rearward end 168 and at the beginningof top finger area 172 and hold hanger bar 182.

The safety shield assembly and the needle assembly are assembledtogether whereby needle 40 is connected to hub 60 and sealed withadhesive at the ends of the hub. Hub 60 is then joined with collar 90 byultra-sonic welding techniques or any other bonding techniques, ormechanical fit, whereby rearward annular skirt 94 of collar 90 mateswith ribbed end 66 of the hub. Male ribs 82 of the hub are contained orforced fitted within inner sidewall 102 of rearward annular skirt 94 ofcollar 90. The collar is aligned with the intravenous end of the needlewhereby the hook arm is aligned with the bevel up of the needle. Thenrigid sleeve 50 is force fitted into inner side wall 96 of forward skirt92 of collar 90 to cover the needle. Channel 220 then is mounted tosupport wall 150. More particularly, as shown in FIGS. 2, 3 and 6A,channel 220 is oriented such that end 224 of channel 220 projectsdistally or forwardly beyond support wall 150. This orientation isappropriate in situations where it is known that a relatively longneedle cannula will be employed with the needle assembly. Alternatively,however, channel 220 can be oriented as shown in FIG. 6B so that end 222of channel 220 is aligned substantially with the distal end 152 ofsupport wall 152 while end 224 of channel 222 projects rearwardly orproximally into rearward end 144 of shield 140. Thereafter, shield 140is connected to collar 90 whereby hanger bar 182 is force fitted intohook member 114 whereby slot 160 faces rigid sleeve 50. Most preferably,the shield is connected to the collar by a force fit or interference fitbetween the hanger bar and the hook bar. Therefore, the shield is alwaysoriented in a stable position and will not move unless movement of theshield is positively initiated by the user. To assemble the last piece,shield 140 is moved towards rigid sleeve 50 and second rigid sleeve 52is force fitted onto outer sidewall 104 of rearward skirt 94 of collar90.

In addition, a label 196 may be applied to the finally assembled parts.The label may be used to prevent tamper resistance of the parts, so thatthey are not reused.

In use, as shown in FIGS. 7-15, the non-patient needle shield is removedand then a needle holder is screwed onto the hub of the needle. Asspecifically shown in FIGS. 8 and 12 the shield is then rotated back bythe user towards the needle holder. Then as shown in FIG. 9, theintravenous needle shield is removed from covering the intravenousneedle. Then as shown in FIG. 10, a venipuncture is conducted wherebythe intravenous end of the needle is inserted into a vein of a patientand an evacuated tube having a closure is inserted into the needleholder. Then as shown in FIGS. 11 and 13, when the venipuncture iscomplete the user easily rotates the shield from the first positiontowards the intravenous needle to an intermediate position and then theuser pushes on the shield at the top finger guide area to move theshield into a second position whereby the needle is trapped in thelongitudinal opening. More particularly, needle 40 contacts cannulafinger locks 234. Accordingly, cannula finger locks 234 deflect towardsupport wall 150 and away from edges 230. Sufficient rotation of shield140 will cause needle 40 to pass cannula finger locks 234. As a result,cannula finger locks 234 will return resiliently to an undeflectedcondition. Thus, needle 40 will be trapped above cannula finger locks234.

Needle 40 is contained within shield 140 as the shield is pivoted intothe closed position. More particularly, proximal surfaces 197 of roundedears 194 move over ramp surfaces 122 of chevron-shaped projection 118and cause sidewalls 174 to deflect away from one another. The angularlyaligned proximal faces 197 of rounded ears 194 ensure easy movement ofshield 140. Additionally, the resiliency of sidewalls 174 and theangular alignment of distal surface 195 of ears 194 causes a cooperationwith rounded proximal ends 124 of chevron-shaped projection 118 toaccelerate shield 140. This accelerated movement of shield 140 helps togenerate a clear audible and tactile indication of complete shielding.

FIGS. 17, 18, and 19 are further embodiments of the invention thatinclude may components which are substantially identical to thecomponents of FIGS. 1-3. Accordingly, similar components performingsimilar functions will be numbered identically to those components ofFIGS. 1-3, except that a suffix “a” will be used to identify thosesimilar components in FIG. 17, a suffix “b” will be used to identifythose similar components in FIG. 18 and a suffix “c” will be used toidentify those similar components in FIG. 19.

Alternatively, the safety shield assembly of the present invention maybe used in conjunction with a conventional intravenous (IV) infusionset, as illustrated in FIG. 17.

For purposes of illustration, shield 140 a and collar 90 a are connectedto a conventional IV infusion set, 200, or butterfly structurecomprising a needle body with a needle hub 204 extending from theforward end of the needle body and a needle 206 embedded in hub 204.Extending from the rearward end of the needle body is flexible tubing208 which is conventional and utilized to allow the user to manipulatethe structure and to connect it subsequently to supplies of infusionliquids or for the return of collected blood if the arrangement is beingused to collect blood.

Infusion set 200 further comprises flexible wings 210 attached to andprojecting outwardly from needle hub 204.

Alternatively, the safety shield assembly of the present invention maybe used in conjunction with a syringe, as illustrated in FIG. 18.

For purposes of illustration, shield 140 b and collar 90 b are connectedto a conventional hypodermic syringe 300 comprising a syringe barrel 302having a distal end 304 a proximal end 306 and a plunger 312.

Alternatively, the present invention may be used in conjunction with acatheter as illustrated in FIG. 19.

FIGS. 20 and 21 show a further alternate to the needle assembliesdescribed and illustrated above. In particular, the embodiment of FIGS.20 and 21 includes a shield 140 d that is similar to the shield 140described and illustrated above. Shield 140 d includes a collar engagingarea 166 d with a top finger guide area 172 d and sidewalls 174 d thatextend downwardly from top finger guide area 172 d. Sidewalls 174 ddiffer from the embodiments described and illustrated above in that theyextend a shorter distance from top finger guide area 172 d and have nomeans for engaging the chevron-shaped projection on the collar.

Shield 140 d includes a forward end 146 d with a top wall 163 d andsidewalls 162 d extending down from top wall 163 d. Top wall 163 d ischaracterized by spaced apart mounting apertures 164 d.

Shield 140 d further includes a channel-shaped clip 220 d having aproximal end 222 d, a distal end 224 d and a top wall 226 d extendingfrom distal end 224 d toward proximal end 222 d. The top wall includes apair of spaced apart mounting projections 228 d that are dimensioned tobe mounted in mounting apertures 158 d on forward end 146 d of shield140 d. Cannula finger locks 230 d extend from the channel-shaped clip ina direction away from mounting projections 228 d. Each cannula fingerlock 230 d includes a support leg and a cannula engaging leg 234 d.Cannula finger locks 230 d are dimensioned and configured to trap theneedle cannula when shield 140 d is rotated into the closed position.

Proximal end 222 d of clip 220 d includes a pair of collar engaging legs236 d extending generally proximally from top wall 226 d. Cannulaengaging legs 236 d are configured to pass around opposite respectivesides of the collar. Ends of collar engaging legs 236 d furthest fromtop wall 226 d are formed with rounded ears 238 d. Ears 238 d areconfigured to snap into engagement with the chevron-shaped projection,as described above.

Shield 140 d is used substantially exactly as shield 140 describedabove. In particular, shield 140 d can be rotated from the open positionto the closed position. As shield 140 d approaches the closed position,cannula engaging legs 234 d of cannula locking fingers locks 230 dengage the needle cannula. Simultaneously, rounded ears 238 d engage thechevron-shaped projection. The rounded configuration of ears 238 d helpsto propel shield 140 d toward the closed position. In the closedposition, cannula finger locks 230 d will snap past the needle cannulafor permanently trapping the needle cannula within shield 140 d.

The shield and collar of the safety shield assembly of the presentinvention are comprised of moldable parts which can be mass producedfrom a variety of materials including, for example, polyethylene,polyvinyl chloride, polystyrene or polyethylene and the like. Materialswill be selected which will provide the proper covering and support forthe structure of the invention in its use, but which will provide also adegree of resiliency for the purpose of providing the cooperativemovement relative to the shield and the collar of the assembly.

A further alternate embodiment is illustrated in FIG. 22, and isvirtually identical to the embodiment of the invention depicted in FIG.15A. As a result, comparable numerals have been employed to identifyidentical or very similar components. FIG. 22, however, differs fromFIG. 15A in that collar 90 does not have the chevron-shaped protrusion118 illustrated in FIG. 15A. Additionally, shield 140 does not have earscomparable to rounded ears 194 of FIG. 15A. Thus, the embodimentillustrated in FIG. 22 relies entirely upon the engagement of cannulafinger locks 234 with needle 40. There are fewer structures on theembodiment of FIG. 22 to achieve the clear audible and tactileindication of complete shielding as in the previous embodiment and nostructure for accelerating shield 140 in to the second position aroundneedle 40. However, upon complete shielding, the retention betweenshield 140 and needle 40 in the embodiment of FIG. 22 is comparable tothe retention achieved by the previous embodiments.

What is claimed is:
 1. A safety needle assembly comprising a needle hubwith proximal and distal ends and a passage extending between said ends,a chevron-shaped projection formed externally on said hub, saidchevron-shaped projection including a central point facing distally onsaid hub and a pair of rounded ends facing proximally on said hub, aneedle cannula mounted to said passage of said needle hub and having apointed distal end projecting beyond said distal end of said hub, ashield having proximal and distal ends, said proximal end of said shieldbeing hingedly mounted to said hub for rotation from a first positionwhere said shield is spaced from said needle cannula to a secondposition where said shield substantially surrounds said needle cannula,said shield comprising at least one support wall and a channel mountedto said support wall, said channel having a top wall and opposed firstand second sidewalls extending from said top wall, at least oneresiliently deflectable cannula finger lock projecting from said firstsidewall angularly toward said top wall, said cannula finger lockdeflecting during rotation of said shield toward said second positionfor trapping said needle cannula, rounded ears formed on said shield forengaging said wherein rounded proximal ends of said chevron-shapedprojection when said shield is in said second position, whereby saidrounded ears and said rounded proximal ends of said chevron-shapedprojection provide audible and tactile indication of said shieldreaching said second position.
 2. The safety needle assembly of claim 1,wherein said top wall of said channel comprises mounting means formounting said channel to said support wall, said channel having oppositefirst and second longitudinal ends, said mounting means being closer tosaid first end of said channel than to said second end, whereby saidchannel can be disposed in either a first rotational orientation or in asecond rotational orientation relative to said proximal end and saiddistal end of said shield for altering positions of said channelrelative to said shield and said needle cannula.
 3. The safety needleassembly of claim 2, wherein said support wall has a distal end remotefrom said proximal end of said shield, said channel being dimensionedsuch that in said second rotational orientation of said channel relativeto said support wall, said second end of said channel projects distallybeyond said distal end of said support wall.
 4. The safety needleassembly of claim 3, wherein said channel is dimensioned such that insaid first rotational orientation, said first end of said channelsubstantially aligns with said distal end of said support wall.
 5. Theneedle assembly of claim 4, wherein said channel is dimensioned suchthat in said first rotational orientation, said second end of saidchannel is substantially adjacent said proximal end of said shield. 6.The safety needle assembly of claim 2, wherein said at least one cannulafinger lock comprises a plurality of cannula finger locks, a first ofsaid cannula finger locks being substantially adjacent said first end ofsaid channel and a second of said cannula finger locks beingsubstantially adjacent said second end of said channel.
 7. The safetyneedle assembly of claim 1, wherein said chevron-shaped projection isdisposed at a location on said hub substantially opposite said hingedconnection of said shield to said hub.
 8. The safety needle assembly ofclaim 7, wherein said rounded ears are formed on inwardly facingsurfaces of said sidewalls of said shield.
 9. The safety needle assemblyof claim 8, wherein said rounded ears are disposed to pass over saidrounded proximal ends of said chevron-shaped projection as shield isrotated into said second position.
 10. The safety needle assembly ofclaim 9, wherein said rounded ears are dimensioned to require deflectionof said sidewalls away from one another as said shield is rotated intosaid second position and as said rounded ears move over said roundedproximal ends of said chevron-shaped projection.
 11. The safety shieldassembly of claim 1, wherein said needle hub comprises an inner tubularportion securely mounted to said needle cannula and an outer collarsecurely mounted over said inner tubular portion, said shield beinghingedly mounted to said collar of said hub.
 12. The safety needleassembly of claim 11, wherein said needle cannula includes a proximalend, said needle cannula extending entirely through said passage of saidhub such that said proximal end of said needle cannula projectsproximally beyond said proximal end of said hub.
 13. The safety needleassembly of claim 12, further comprising an elastomeric sleeve mountedover said proximal end of said needle cannula and securely engaged tosaid proximal end of said hub.
 14. The safety needle assembly of claim1, further comprising a medical device connected to said needle hub. 15.The safety needle assembly of claim 14, wherein the medical devicecomprises a holder for releasably receiving a fluid collection tube. 16.The safety needle assembly of claim 14, wherein the medical device is asyringe.
 17. The safety needle assembly of claim 14, wherein the medicaldevice comprises an intravenous infusion set.
 18. The safety needleassembly of claim 1, wherein each said rounded ear comprises a proximalface aligned to said respective sidewall at an acute angle, a distalface aligned to said respective side wall at an acute angle and a curvedsurface extending between said proximal and distal faces.
 19. The safetyneedle assembly of claim 18, wherein said distal face of each said earis aligned to said respective sidewall at an angle of approximately 60°.20. The safety needle assembly of claim 1, wherein said support wallcomprises a plurality of apertures extending therethrough, said channelhaving a plurality of mounting projections formed thereon, said mountingprojections being dimensioned and disposed for locked engagement withsaid apertures in said support wall.
 21. The safety needle assembly ofclaim 1, wherein portions of said shield adjacent said proximal end areconfigured for partly surrounding said hub, said support wall extendingsubstantially rigidly from said portions of said shield dimensioned forpartly surrounding said hub.
 22. The safety needle assembly of claim 1,wherein said channel has an elongate convexly arcuate outer surface,said support wall having a concave surface for closely receiving saidconvex outer surface of said channel.
 23. The safety needle assembly ofclaim 1, wherein said rounded ears are formed unitarily with saidsidewall of said channel.